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Marijuana in Combination With Opioids in Palliative and Hospice Patients

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ClinicalTrials.gov Identifier: NCT03233633
Recruitment Status : Enrolling by invitation
First Posted : July 28, 2017
Last Update Posted : August 31, 2017
Sponsor:
Information provided by (Responsible Party):
Theodore Zanker MD, The Connecticut Hospice Inc.

Brief Summary:

Study Objectives: Primary reduction of pain and reduction in overall opioid utilization. Secondary improvement in overall patient well being, weight stabilization with increased appetite, improved oxygen saturation, improvement or prevention of nausea and vomiting.

Study Rationale: To determine optimum use and dosing of medical marijuana (CBD:THC) for pain and symptom management.

Study Population: This study specifically will enroll cancer and non-cancer patients as a primary diagnosis suffering from pain and having a terminal illness (defined as having less than 6 months to live) requiring end of life care.


Condition or disease Intervention/treatment Phase
Pain Management in Terminally Ill Patients Receiving Scheduled Opioid Therapy Drug: Medical Marijuana Phase 1

Detailed Description:

Primary Endpoint: Death or discharge

Secondary and Exploratory endpoints:Secondary improvement in overall patient well being, weight stabilization with increased appetite, improved oxygen saturation, improvement or prevention of nausea and vomiting.

Study design: This will be an open-label study. Patients will choose to participate in a Marijuana adjuvant treatment group, receiving marijuana in combination with standard opioid therapy.

Subject number: Minimum 66 patients

Treatment Duration: Minimum 5 days

Duration of follow up: Patients' initial opioid dose, dosing schedule and numeric pain score will be recorded. For the duration of the study (at least five days) changes in opioid doses and numeric pain scores will be tracked daily.

Marijuana will be administered to the patient via oral route three times daily for at least five days. Patients will receive standardized CBD:THC product provided by NIDA.

On admission to the study, a modified Edmonton Symptom assessment scale to quantify baseline appetite, depression, nausea, vomiting, overall well-being, and anxiety.

Data Tracking: Primary objective tracking will include average numeric pain scores and number of opioid dosage increases and average daily opioid amount (mg equivalents of morphine). Secondary objectives include Weight, Appetite, N/V, O2 Saturation, Self-reported data points from the modified Edmonton Assessment Scale.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 66 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Marijuana in Combination With Opioids for Pain and Symptom Control in Hospice Patients
Actual Study Start Date : May 10, 2017
Estimated Primary Completion Date : August 2018
Estimated Study Completion Date : September 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Single treatment arm
marijuana adjuvant treatment group utilizing scheduled opioid therapy in inpatient hospice hospital setting
Drug: Medical Marijuana
oral capsule, high ratio CBD:THC
Other Names:
  • cannabidiol
  • medical cannabis




Primary Outcome Measures :
  1. primary reduction of pain and reduction in overall opioid utilization [ Time Frame: minumum 5 days ]
    numeric pain scale


Secondary Outcome Measures :
  1. improvement in overall patient well being [ Time Frame: minimum 5 days ]
    modified Edmonton Assessment Scale

  2. weight stabilization with increased appetite [ Time Frame: minimum 5 days ]
    modified Edmonton Assessment Scale

  3. improved oxygen saturation [ Time Frame: minimum 5 days ]
    modified Edmonton Assessment Scale

  4. improvement or prevention of nausea and vomiting [ Time Frame: minimum 5 days ]
    modified Edmonton Assessment Scale



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age > 18
  • Alert adults
  • requiring opioids for pain management (routine or as needed)
  • cancer diagnosis or non-cancer diagnosis as their terminal illness

Exclusion Criteria:

  • pregnant women
  • Age < 18
  • minimally or unresponsive patients unable to take oral medications
  • agitated combative patients

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03233633


Locations
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United States, Connecticut
The Connecticut Hospice Inc.
Branford, Connecticut, United States, 06405
Sponsors and Collaborators
The Connecticut Hospice Inc.
Investigators
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Principal Investigator: Theodore Zanker, MD The Connecticut Hospice Inc.

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Responsible Party: Theodore Zanker MD, Principal Investigator, The Connecticut Hospice Inc.
ClinicalTrials.gov Identifier: NCT03233633     History of Changes
Other Study ID Numbers: WIRB Protocol 20161880-1167645
First Posted: July 28, 2017    Key Record Dates
Last Update Posted: August 31, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Theodore Zanker MD, The Connecticut Hospice Inc.:
pain management
terminally ill